OTC Medication Information: Hand Sanitizer Frosted Coconut

HAND SANITIZER FROSTED COCONUT- alcohol gel
BASE4 Ventures, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Alcohol 66%

Purpose

Antiseptic

Use

  • To decreae bacteria on the skin.

Warnings

  • For external use only.
  • Flammable, keep away from fire & flame
  • Does not contain grain alcohol; do not drink. If taken internally will produce severe gastic disturbances

When using this product

  • Avoid the eyes and mucous membranes
  • In the case of eyes or mucous membrane contact, rinse area thoroughly with water

Stop use and ask a doctor if

  • Condition worsens
  • Redness or irritation develops
  • Condition persists for more than 3 days

Keep out of reach of children.

  • If swallowed contact a doctor or Poison Control Center immediately.

Directions

  • Rub dime sized amount between hands until dry
  • Supervise children in the use of this product
  • In the case of eye contact rinse eyes thoroughly with water

Other Information

  • Store below 105ºF.
  • May discolor fabrics.

Inactive ingredients:

Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance, D&C Red No.33, Blue No.1.

Questions?

Call 1-888-988-2427

Package Labeling:

Label5
(click image for full-size original)

HAND SANITIZER FROSTED COCONUT
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62651-060
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 66 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
AMINOMETHYLPROPANOL
D&C RED NO. 33
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62651-060-01 30 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/15/2021
Labeler — BASE4 Ventures, Inc (137316126)
Establishment
Name Address ID/FEI Operations
Ganzhou Olivee Cosmetic Co., Ltd. 543008195 manufacture (62651-060)

Revised: 04/2021 BASE4 Ventures, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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